Preparation of Cefuroxime Axetil Tablets by Dry Granulation / 中国药房

ABSTRACT

OBJECTIVE:To study the dry granulating technology in the preparation of cefuroxime axetil tablets so as to establish the preparative method.METHODS:With granule size,fluidity and yield as indexes to optimize the dry granulating technology for cefuroxime axetil tablets,and a comparative study was conducted on quality and stability of the samples prepared by wet process.RESULTS:The optimum conditions for the dry granulating technique were as follows:hydraulic pressure = 2.5～3 MPa,extrusion rate = 15～20 r?min-1,powder feed rate=200～300 g?min-1.The extrusion thickness was controlled at 1～2 mm.By circular dry granulating method,the proportion of qualified granules(16～30 meshes) was as high as above 90%,with an angle of repose of 30? and good mobility,and the yield was about 94%,with all indexes in line with the standards specified in Chinese Pharmacopoeia(2005 edition) in the accelerated test and permanent stability test.CONCLUSION:The optimized technological parameters and the mildly readjusted formulation can meet the requirements for the dry granulation method,with the stability of the product superior to that by wet method,and this method has a good reproducibility and shorter production cycle.